Intravenous (IV) solutions are typically sterile liquid doses produced in containers varying in size from 50 mL to 1000 mL. These IV solutions may be basic chemical solutions used for hydration, the most common being 0.9% Sodium Chloride (sometimes referred to as saline or normal saline), and Dextrose 5% in Water (D5W). Many containers for these solutions are plastic bags, plastic bottles, or glass bottles. These solutions are currently manufactured in fluid form, delivered to healthcare institutions, and stored there for use. They are used in the U.S. alone in quantities of millions.
The state of the art described above can have, in various circumstances, one or more drawbacks, excess costs, and/or complications. For example, current IV solutions are commonly stored, shipped, and used as complete fluid products, which means that they require immense amounts of storage space, are heavy, and are expensive to ship.
Additionally, many commonly used drugs are not chemically stable in a solution, with the result that doses containing these drugs cannot easily be manufactured with sufficient shelf life to survive the quality/regulatory systems required for their manufacture, much less the time required to get them into, and through the supply chain to their end-users. Conventional approaches to this chemical stability problem include: (a) manual preparation in healthcare facilities—i.e., the drugs must be liquefied and injected into liquid IV solutions prior to administration, (b) special adapters to IV fluid containers that permit a vial of the drug to be attached to an IV solution for activation just before use (e.g., the Baxter MiniBag Plus®, or Hospira ADDvantage®), and (c) freezing, in which, when the drug chemistry permits, the IV dose is prepared and frozen to limit degradation. However, each of these conventional approaches can have, if care is not taken, one or more drawbacks.
In the case of manual preparation, the preparation can be hazardous both due to human error and due to contamination of the preparation. Manual preparation can also be labor-intensive, highly regulated, and require special facilities to ensure sterility and potency. Such manual preparation is, perforce, centralized in the pharmacy, which limits the pace at which doses can be prepared and delivered for patient use.
In the case of special adapter containers, the IV solutions add cost and the ingredients must be physically attached to the bag by a caregiver, the ingredients must be activated at run time—i.e., the caregiver must attach the vial to the IV solution container, activate it, move fluid from the IV solution container to the vial, dissolve the contents of the vial, and move the dissolved contents back to the IV solution container. If care is not taken, there can be a 2-3% failure-to-activate rate with conventional special adapter containers. Moreover, with special adapter containers, the number of different types of vials that can be delivered this way is small because many vials cannot be used with the special adapter and drugs delivered in glass ampules also cannot be delivered in this way.
In the case of freezing, special supply chain equipment and processes are commonly required to ensure the frozen state is maintained during storage and delivery, the doses must be stored frozen until needed and then thawed, thawing can be messy and requires additional space and equipment (e.g., for management of condensation), and, once thawed, the pharmacy is required to relabel each dose with new expiration dating based on the date of thawing.
Accordingly, improved systems and methods for providing IV solutions would be desirable.